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Anti-metabolites

Combination Therapy for Esophageal Cancer

Phase 2

Waitlist Available

Led By Michael McNamara, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a histologic diagnosis of adenocarcinoma of the esophagus, GEJ, or GC based on biopsy material or adequate cytologic exam; tumors of the GC are defined as originating within 5 cm of the GEJ

Patients must be clinically staged according to the 7th edition (2010) of the American Joint Committee on Cancer (AJCC) staging system and must have either clinical T3-4a, or ≥ N1 disease; staging should include upper endoscopy with endoscopic ultrasound and a fludeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) scan (with diagnostic CT abdomen/pelvis preferred)

Must not have

Patients with any other diagnosis except for adenocarcinoma (squamous cell carcinoma, small cell carcinoma, mixed adenosquamous, lymphoma, sarcoma, etc.) will be ineligible

Patients with a baseline peripheral neuropathy ≥ grade 2 will not be eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat cancer of the esophagus, and will compare it to the standard of care.

Who is the study for?

This trial is for adults with specific cancers of the esophagus, gastroesophageal junction, or gastric cardia. They must be in good physical condition (ECOG 0-1), have adequate blood counts and organ function, and no severe neuropathy. Pregnant women, those with distant metastasis or another active cancer (with some exceptions), prior treatments for this cancer, certain infections like hepatitis B/C or HIV, serious heart conditions, or other medical issues that could affect participation are excluded.

What is being tested?

The study tests a combination of chemotherapy drugs (oxaliplatin, leucovorin calcium, fluorouracil) followed by surgery and then more chemo alongside radiation therapy based on how well the patient responds to initial treatment. The goal is to see if this approach is effective at stopping tumor growth by killing cells or preventing them from dividing.

What are the potential side effects?

Possible side effects include reactions to chemotherapy such as nausea, vomiting, diarrhea; low blood cell counts leading to increased infection risk; nerve damage causing numbness; fatigue; liver enzyme changes; and potential complications from radiation therapy like skin irritation and difficulty swallowing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of adenocarcinoma located in my esophagus, GEJ, or stomach.

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My cancer is at a specific stage and has been confirmed with certain tests.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer diagnosis is specifically adenocarcinoma.

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I do not have severe numbness or pain in my hands or feet.

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My cancer is not classified as T4b (unresectable) or M1 (spread to distant areas).

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I do not have angina, heart failure with an ejection fraction below 50%, or ischemic heart disease.

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I do not have a history of hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recurrence Free Survival (RFS) compared to historical averages

Secondary study objectives

Complete resection (R0) rate

Endoscopic response

Incidence of toxicity

+6 more

Other study objectives

Change in Ki-67 expression

Change in circulating tumor cells (CTCs)

HER2 overexpression

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Negative Pathologic ResponseExperimental Treatment7 Interventions

Patients with \>50% viable tumor cells remaining in the surgical specimen, will receive postoperative chemo-radiotherapy with weekly carboplatin and paclitaxel.

Group II: Positive Pathologic ResponseActive Control5 Interventions

Patients with ≤50% viable tumor cells remaining in the surgical specimen will receive postoperative chemo-radiotherapy with the mFOLFOX6 regimen

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

leucovorin calcium

1999

Completed Phase 3

~8620

oxaliplatin

2002